Full TitleA Phase II Trial of Adimlecleucel (Third Party Donor Derived CMVpp65 specific T-cells) for The Treatment of CMV Infection or Persistent CMV Viremia after Allogeneic Hematopoietic Stem Cell Transplantation, solid organ transplant, human immunodeficiency virus, other immunocompromised states, and immune competent subjects who require therapy
Cytomegalovirus (CMV) is a potential complication after stem cell transplantation. There are drugs used to treat CMV, but in some patients the virus has become resistant to these drugs, or the patient cannot tolerate them. In these cases, giving infusions of T cells (infection-fighting white blood cells) that are immune to CMV may be a potentially effective treatment.
In this study, researchers are evaluating the effectiveness of giving CMV-immune T cells from a “third party” to patients with persistent CMV infection after transplantation of stem cells from a donor. Third-party donors are used for patients whose donors don’t have CMV-immune stem cells or when the donor is not available. The T cells are donated by another person , a third party who is partially matched to the patient’s tissue type and whose T cells are immune to CMV. The immuneT cells contributed by the third-party donor are grown and selected in the laboratory for their ability to kill CMV infected cells.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have CMV infection after allogeneic stem cell transplantation which is not responding despite more than two weeks of conventional CMV treatment.
- This study is for patients whose donors don’t have CMV-immune stem cells or whose donors are not available.
- Patients of all ages are eligible to participate.